It is well-known that a number of human disease states may be characterized by the over-production of certain types of leukocytes, including lymphocytes, in comparison to other populations of cells that normally comprise whole blood. Excessive or abnormal lymphocyte populations can result in numerous adverse effects to patients, including the functional impairment of bodily organs, leukocyte-mediated autoimmune diseases and leukemia-related disorders.
As a result, there have been proposed numerous apparatus and processes for treating human blood in such a manner as to moderate the viability of given cellular populations in order to provide relief for patients suffering from diseases and disorders such as those discussed above. Generally, such apparatus and processes involve the treatment of blood with a drug that is capable of forming photoadducts with DNA in the presence of certain types of radiation, such as ultraviolet (or "U.V.") radiation.
The bulk of such conventionally known apparatus and processes involve what is termed "extracorporeal" irradiation, whereby the irradiation of the blood or blood products takes place away from the body of the patient. Some conventional apparatus and processes involving extracorporeal irradiation are to be found in the following U.S. patents to R. Edelson: U.S. Pat. Nos. 4,321,919; 4,398,906; 4,428,744; and 4,464,166. Also, the article "Treatment of Leukemia. CTCL with extracorporeally photoactivated 8-MOP" by R. Edelson et al. (American Association of Clinical Investigators, Annual Meeting, May 1, 1983, Washington, D.C.) provides further background information on this subject.
Departing from known apparatus and processes such as those alluded to above, various refinements have been made with the objective of increasing the efficiency, safety and accuracy of the irradiation procedures being performed.
For example, U.S. Pat. No. 4,727,027 to Wieshahn et al. discloses the decontamination of blood and blood components via treatment with furocoumarin derivatives, followed by irradiation, with UV-A radiation having a wavelength between about 300-400 nm, at an intensity between 0.1 mW/cm and 5.0 w/cm.
U.S. Pat. No. 5,459,322 to Warkentin discloses methods and apparatus for exposing a blood-based sample to ultraviolet radiation. Particularly, a sample contained within a shielded housing is permitted to be exposed to a source of ultraviolet radiation and simultaneously observed. The sample rests on a stage that can be moved relative to the source of the ultraviolet radiation while the irradiation is taking place, so that the effect of ultraviolet radiation upon given biological materials (such as blood) can be determined. It is contemplated therein that the movement of the stage be controlled by a set of lead screws.
The article "Extracorporeal Photochemotherapy: Evaluation of Two Techniques and Use in Connective Tissue Disorders", by G. Andreu et al., as found in Transfusion Science, Vol. 15, No. 4, pp. 443-454 (1994), compares and contrasts two different techniques for irradiating human blood.
There are disclosed, in U.S. Pat. Nos. 4,850,995, 4,708,712, and 4,647,279 (to Tie et al.; Mulzet; and Mulzet et al., respectively), some methods and apparatus involving the centrifugal separation of blood.
Finally, it is known to use, for irradiation during photophoresis procedures, an arrangement that includes a recirculating pump chamber, a conventional intravenous ("I.V.") bag, and an irradiation chamber, as well as tubing for interconnecting the bag with the irradiation chamber. In one such known device, the bag is designed to create a vortex therewithin, in order to keep the blood products evenly mixed. Also, a separate roller pump is used for the purpose of recirculating the blood products. At least portions of this known device, and components therefor, are contemplated in several U.S. patents, including: U.S. Pat. No. 4,708,715 to Troutner et al.; U.S. Pat. No. 4,692,138 to Troutner et al. and U.S. Pat. No. 4,737,140 to Lee et al.
As a matter of further explanation, a device such as that described immediately above often involves what may be termed a "closed-loop" system of circulating blood products through an irradiation chamber. In this respect, an irradiation chamber is provided with essentially rigid through-passages, whereby a bag (or what may be alternatively termed a "vortex bag") feeds into the through-passages of the irradiation chamber via the aforementioned interconnecting tubing. Likewise, portions of the aforementioned interconnecting tubing feed irradiated blood products back to the "vortex bag." Upon the achievement of a predetermined number of flow cycles, i.e., from the "vortex bag" to the irradiation chamber and back, the "vortex bag" is removed and subsequently mounted in a manner that permits propagation of the irradiated blood products back to the patient.
U.S. Pat. Nos. 4,952,812, and 4,726,949, both to Miropol et al., disclose methods in which a thin film of white blood cells are irradiated within the UV-B band at a wavelength of 280-320 nanometers (nm). These two patents to Miropol et al. also appear to disclose arrangements for accommodating a flat, flexible bag in an ultraviolet irradiation apparatus, and contemplate that, for the irradiation process, blood cells be provided in a thin film that is inserted between two banks of UV-B bulbs mounted a fixed distance apart, within a specially designed cabinet.
Generally, the apparatus and processes proposed to date, including those disclosed in the patents and publications discussed hereinabove, have often involved the use of arrangements, components, and procedures that can tend to be complex and expensive. Further, many of the apparatus and processes proposed to date, including many of those disclosed in the patents and publications discussed hereinabove, have often failed to: adequately irradiate blood products continuously with U.V. light; prevent stagnation of the blood products and evenly expose all constituents; adequately control the temperature of the blood products being irradiated; adequately afford access to irradiation lamps; be appropriately sized so as to facilitate incorporation into a greater apparatus or instrument; and adequately protect users from harmful U.V. light and aerosols.
Accordingly, an advantage would appear to exist in connection with:
an arrangement for irradiating blood products continuously and effectively with U.V. light while providing gentle agitation to prevent stagnation and to evenly expose all constituents; PA1 adequate control of the temperature of blood products being irradiated; PA1 easy access to irradiation lamps to facilitate their renewal or replacement; and PA1 protection of the user from harmful U.V. light and aerosols. PA1 a radiation-permeable arrangement for holding at least one human blood product; PA1 an arrangement for irradiating at least one human blood product held in the radiation-permeable holding arrangement; and PA1 an arrangement for displacing at least a portion of the irradiating arrangement at least during irradiation of the at least one blood product. PA1 an arrangement for withdrawing blood from a human patient; PA1 an arrangement for separating blood, having been withdrawn from a human patient by the withdrawing arrangement, into selected blood products; PA1 an arrangement for temporarily storing at least one blood product having been separated by the separating arrangement; PA1 the storing arrangement comprising a contiguous, self-contained arrangement, the contiguous, self-contained arrangement comprising a port arrangement for permitting the entry and egress of at least one blood product into and out of the contiguous, self-contained arrangement; PA1 an arrangement for irradiating at least one blood product held in the contiguous, self-contained arrangement, the irradiating arrangement comprising a radiation source for emitting radiation towards the contiguous, self-contained arrangement; PA1 an arrangement for supporting the contiguous, self-contained arrangement while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; PA1 an arrangement for optimizing exposure of at least one blood product being held in the contiguous, self-contained arrangement to radiation emitted by the radiation source while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; and PA1 the arrangement for optimizing exposure comprising: PA1 an arrangement for displacing the contiguous, self-contained arrangement while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source, to displace the at least one blood product held within the contiguous, self-contained arrangement and maximally expose the at least one blood product to the radiation emitted by the radiation source; and PA1 an arrangement for maintaining a substantially constant distance between the radiation source and the at least one blood product held in the contiguous, self-contained arrangement during displacement of the contiguous, self-contained arrangement. PA1 an arrangement for temporarily storing at least one blood product; PA1 the storing arrangement comprising a contiguous, self-contained arrangement, the contiguous, self-contained arrangement comprising a port arrangement for permitting the entry and egress of at least one blood product into and out of the contiguous, self-contained arrangement; PA1 an arrangement for irradiating at least one blood product held in the contiguous, self-contained arrangement, the irradiating arrangement comprising a radiation source for emitting radiation towards the contiguous, self-contained arrangement; PA1 an arrangement for supporting the contiguous, self-contained arrangement while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; PA1 an arrangement for optimizing exposure of at least one blood product being held in the contiguous, self-contained arrangement to radiation emitted by the radiation source while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; and PA1 the arrangement for optimizing exposure comprising: PA1 an arrangement for temporarily storing at least one blood product; PA1 the storing arrangement comprising a contiguous, self-contained arrangement, the contiguous, self-contained arrangement comprising a port arrangement for permitting the entry and egress of at least one blood product into and out of the contiguous, self-contained arrangement; PA1 an arrangement for irradiating at least one blood product held in the contiguous, self-contained arrangement, the irradiating arrangement comprising a radiation source for emitting radiation towards the contiguous, self-contained arrangement; PA1 a housing arrangement for encasing the irradiating arrangement; PA1 an arrangement for supporting the contiguous, self-contained arrangement while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; PA1 an arrangement for optimizing exposure of at least one blood product being held in the contiguous, self-contained arrangement to radiation emitted by the radiation source while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source; and PA1 an arrangement for cooling the radiation source while radiation is being emitted toward the contiguous, self-contained arrangement from the radiation source. PA1 a radiation source for emitting radiation towards a contiguous, self-contained arrangement, to irradiate at least one blood product held within the contiguous, self-contained arrangement; PA1 an arrangement for supporting the contiguous, self-contained arrangement during irradiation of at least one blood product held within the contiguous, self-contained arrangement; PA1 an arrangement for optimizing exposure of at least one blood product held in the contiguous self-contained arrangement to radiation emitted by the radiation source while the at least one blood product is being irradiated; and PA1 the arrangement for optimizing exposure comprising arrangement for displacing at least a portion of the radiation source while radiation is being emitted towards the contiguous, self-contained arrangement from the radiation source.